Class 2 Device Recall C3 Wave App

• Date Initiated by Firm: October 01, 2018
• Create Date: October 25, 2019
• Recall Status: Terminated on October 01, 2020
• Recall Number: Z-0222-2020
• Recall Event ID: 81439
• 510(K)Number: K170934
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: C3 Wave App, v. 2.0.5
• Code Information: v. 2.0.5; all units
• Recalling Firm/ Manufacturer: Medical Components, Inc dba MedComp; 1499 Delp Dr; Harleysville PA 19438-2936
• For Additional Information Contact: Compliance Department; 215-256-9191
• Manufacturer Reason for Recall: When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.
• FDA Determined Cause: Software Manufacturing/Software Deployment
• Action: On October 1, 2018, the firm notified its customers via Product Advisory Notification letter. The letter communicated to customers that the most recent iOS version (12) was incompatible with the C3 Wave app v. 2.0.5. The firm released v.2.0.6 of the app on 10/3/2018, which was made available in the app store. Customers were asked to update both the iOS and the C3 app at the same time to avoid any issues within the app. Customers were provided with step-by-step directions on how to do this. If you have any questions, please contact Recalls@medcompnet.com.
• Quantity in Commerce: 24
• Distribution: Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJS